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Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer — ODYSSEY  

Prostatic Neoplasm Clinical Trial

Official title:
Evaluation of Two Doses of SR31747A (75 mg and 125 mg) in Non-Metastatic Androgen-Independent Prostate Cancer. Randomized, Double-Blind, Placebo Controlled Phase II Study

Clinical Trial Summary

To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00174863
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date October 2003
Completion date August 2006
View Details
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